Regulatory requirements related to equipment design and qualification, facilities design and qualification, personnel, procedures, training, process control, quality risk management, process validation, maintenance, and quality systems are defined in various national regulations. However, the volume of requirements and range of information and data required to be managed by compliance with such requirements can often be too burdensome for compliance by enterprises operating in heavily regulated environments.
For example, the regulatory requirements related to equipment design and qualification, facilities design and qualification, personnel, procedures, training, process control, quality risk management, process validation, maintenance, and quality systems are defined in various national regulations.
Further, international standards and guidance documents provide further approaches adopted by much of the pharmaceutical and biotech industry and generally followed by regulators. These different dimensions of regulatory requirements are tightly inter-related: training to procedures, training to personnel qualification, equipment design and qualification to process user requirements and quality risk control, maintenance and calibration to process user requirements and quality risk control, etc.
There are a number of conventional information technology solutions developed that support many of these requirements, but few of those solutions deal with multiple requirements.
For example, TrackWise® is an enterprise quality management software solution from Sparta Systems that optimizes quality systems management across a range of industries.
Trackwise® provides corrective and preventive actions, process deviations, training records, other compliance tracking.
Maximo® (and many other Computerized Maintenance Management Software applications) provide maintenance and calibration scheduling and record keeping.
Documentum® is an enterprise content management platform that provides document management.
Further, various other conventional IT solutions provide automated qualification and validation protocol development and still further conventional solutions provide equipment and instrument data tracking during construction and turnover as well as generation of verification forms.
Additionally, there are various conventional IT products that manage training records and spreadsheets of many varieties that are conventionally used for quality risk assessments and risk controls.